Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.
|Osteoarthritis||Procedure: Liposuction with Local Anesthesia Biological: Intra articular infusion of AD-SVF||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis|
- Change from Baseline in Visual Analogue Scale (VAS) [ Time Frame: 3 months, 6 months ]For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.
- Change from Baseline of Quality of life scores [ Time Frame: 3 months, and 6 months ]
- Change from Baseline of Reduction in analgesics [ Time Frame: Baseline, 3 months, 6 months ]
- Number of adverse events reported [ Time Frame: 6 months ]
- Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline. [ Time Frame: 6 months ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Experimental: Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
Procedure: Liposuction with Local Anesthesia
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Other Names:Biological: Intra articular infusion of AD-SVF
Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739504
|Contact: Janette M Daher||9547447400 ext email@example.com|
|Contact: Sharon McQuillan, MDfirstname.lastname@example.org|
|United States, Florida|
|Ageless Institute LLC||Recruiting|
|Aventura, Florida, United States, 33180|
|Contact: Sharon McQuillan, MD 305-933-2988 email@example.com|
|Principal Investigator: Sharon McQuillan, MD|
|Sub-Investigator: Moises Irizarry, MD|
|Principal Investigator:||Sharon McQuillan, MD||Ageless Regenerative Institute|